UnitedHealthcare Kerendia Prior Auth Policy Update

Coverage Criteria

Initial Authorization — CKD with T2D

Covered when ALL of the following are met

CKD with T2D criteria: 1) Diagnosis of chronic kidney disease (CKD) associated with type 2 diabetes (T2D); 2) Urinary albumin-to-creatinine ratio (UACR) >= 30 mg/g; 3) eGFR >= 25 mL/min/1.73 m2; 4) Use is intended to reduce risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, or hospitalization for heart failure; 5) Serum potassium <= 5 mEQ/L prior to initiating treatment; 6) Either (a) patient is on a stabilized dose and receiving concomitant maximally tolerated ACE inhibitor or ARB, or (b) patient has allergy, contraindication, or intolerance to ACE inhibitors and ARBs; 7) Prescriber attests the patient’s diabetes is being managed with a diabetes medication with proven CKD benefit (e.g., SGLT2 inhibitor such as Jardiance or a GLP‑1 RA such as Ozempic).

Reauthorization

Reauthorization requirements

Reauthorization: Documentation of positive clinical response to therapy is required for continued approval

Initial Authorization — HFpEF

Covered when ALL of the following are met

HFpEF criteria: 1) Diagnosis of heart failure with preserved ejection fraction (HFpEF); 2) Ejection fraction >= 50%; 3) eGFR >= 25 mL/min/1.73 m2; 4) Serum potassium <= 5 mEQ/L prior to initiating treatment; 5) Either (a) patient is on a stabilized dose and receiving concomitant maximally tolerated ACE inhibitor, ARB, or ARNI, or (b) patient has allergy, contraindication, or intolerance to these agents; 6) Either (a) patient is on a stabilized dose and receiving concomitant therapy with a SGLT-2 inhibitor (e.g., Jardiance) or (b) patient has allergy, contraindication, or intolerance to a SGLT-2 inhibitor; 7) Trial and failure, contraindication, or intolerance to a mineralocorticoid receptor antagonist (MRA) such as spironolactone or eplerenone is required.

Initial Authorization — HFmrEF

Covered when ALL of the following are met

HFmrEF criteria: 1) Diagnosis of heart failure with mildly reduced ejection fraction (HFmrEF); 2) Ejection fraction 40% to <50%; 3) eGFR >= 25 mL/min/1.73 m2; 4) Serum potassium <= 5 mEQ/L prior to initiating treatment; 5) Either (a) patient is on a stabilized dose and receiving concomitant maximally tolerated ACE inhibitor, ARB, or ARNI, or (b) patient has allergy, contraindication, or intolerance to these agents; 6) Either (a) patient is on a stabilized dose and receiving concomitant therapy with a SGLT-2 inhibitor (e.g., Jardiance) or (b) patient has allergy, contraindication, or intolerance to a SGLT-2 inhibitor; 7) Either (a) patient is on a stabilized dose and receiving concomitant beta-blocker therapy (e.g., carvedilol, metoprolol succinate, bisoprolol) or (b) patient has allergy, contraindication, or intolerance to a beta-blocker; 8) Trial and failure, contraindication, or intolerance to a mineralocorticoid receptor antagonist (MRA) such as spironolactone or eplerenone is required.

Reauthorization

Reauthorization criteria

Reauthorization: Documentation of positive clinical response to therapy is required for continued approval

Authorization duration is 12 months

The policy allows documented allergy, contraindication, or intolerance to required concomitant agents (for example, ACE inhibitors or ARBs) to satisfy pathways where those agents are otherwise required. This alternate pathway is explicitly stated as an OR option when a patient cannot tolerate or has a contraindication to ACE inhibitor/ARB therapy, and may be applied in initial authorization determinations when appropriate documentation is provided.

Supply limits may be applied to Kerendia claims and coverage can be affected by applicable state mandates, federal requirements, and the member’s specific benefit plan. UnitedHealthcare may use previous claim or medication history, diagnosis codes (ICD-10), and automated claim logic in approval or reauthorization decisions; these utilization management processes can modify how limits and plan rules are enforced.

Use of finerenone (Kerendia) outside the listed indications or without meeting the baseline clinical requirements — including the specified diagnosis, UACR >= 30 mg/g, eGFR >= 25 mL/min/1.73 m2, baseline serum potassium <= 5 mEq/L, and required concomitant or trialed therapies — does not meet the medical necessity criteria in this policy and would not be approved under the stated coverage criteria.

Clinical Thresholds & Coding

eGFR — numeric threshold used across indications

eGFR threshold>= 25 mL/min/1.73 m2

Applies to indicationsRequired baseline for CKD with T2D, HFpEF, and HFmrEF prior to initiation

Denial riskeGFR below this threshold may trigger denial of therapy

UACR — albuminuria threshold

UACR threshold>= 30 mg/g

IndicationRequired for CKD associated with T2D prior to approval

DocumentationUACR must be submitted with prior authorization request

Provider Actions & Documentation Requirements

Step Therapy

Step therapy requirements

Step therapy: Trial and failure, contraindication, or intolerance to a mineralocorticoid receptor antagonist (MRA) is required for initial authorization in HFpEF and HFmrEF. For CKD with T2D, prescriber must attest that the patient's diabetes is being managed with a diabetes medication with proven CKD benefit (e.g., SGLT2 inhibitor or GLP-1 RA) or document contraindication/intolerance. Supply limits may apply.

MRA trial/failure requirement applies to HFpEF and HFmrEF (e.g., spironolactone, eplerenone).
SGLT2 requirement modified to provider attestation statement — prescriber attests diabetes is managed with a medication with proven CKD benefit (e.g., Jardiance) or documents allergy/contraindication/intolerance.
Automated approvals may be based on prior claim/medication history and diagnosis codes; use of automated processes varies by program.
Supply limits may be in place.

Documentation Required

Required documentation

Providers must include required clinical documentation with prior authorization requests: diagnosis (CKD with T2D, HFpEF, or HFmrEF as applicable), baseline labs (UACR, eGFR, serum potassium), ejection fraction for HF indications, and documentation of concomitant/stabilized therapy or attestation where required. For reauthorization, include documentation of positive clinical response and, when available, prior claim or medication history to support continued use.

Initial Therapy Criteria by Indication

Initial Therapy — Initial authorization criteria by indication (grouped)

Initial authorization criteria by indication

CKD with T2D initial: See Initial Authorization — CKD with T2D criteria set

HFpEF initial: See Initial Authorization — HFpEF criteria set

HFmrEF initial: See Initial Authorization — HFmrEF criteria set

Initial Therapy — Initial approval requirements

Initial approval requirements

Reauthorization & Continuation Criteria

Continuation — Reauthorization/continuation requirements

Reauthorization/continuation requirements

Continuation: Documentation of positive clinical response to therapy required for reauthorization; authorizations are issued for 12 months.

Continuation Therapy — Reauthorization and continuation specifics

Reauthorization and continuation

Continuation: Reauthorization requires documentation of positive clinical response to therapy; authorizations are issued for 12 months.

Approvals may also be granted based on previous claim/medication history, diagnosis codes, or claim logic per policy rules.

Step Therapy Requirements

Requirement	Details
Prior use of ACE inhibitor or ARB (or documented intolerance/contraindication)
Patient is on a stabilized dose and receiving concomitant maximally tolerated ACE inhibitor (e.g., captopril, enalapril) OR maximally tolerated ARB (e.g., candesartan, valsartan), or has documented allergy/contraindication/intolerance to ACEi and ARB.
Diabetes medication with proven CKD benefit (prescriber attestation)
Prescriber attests the patient’s diabetes is being managed with a diabetes medication with proven CKD benefit (e.g., SGLT2 inhibitor such as Jardiance, or a GLP-1 receptor agonist such as Ozempic).
Prior trial/failure, contraindication, or intolerance to a mineralocorticoid receptor antagonist (MRA)
Trial and failure, contraindication, or intolerance to an MRA (e.g., spironolactone, eplerenone) is required before approval.
SGLT-2 inhibitor concomitant use or intolerance/contraindication
For heart failure indications and initial therapy criteria: either patient is on a stabilized dose and receiving concomitant therapy with an SGLT-2 inhibitor (e.g., Jardiance) OR has an allergy, contraindication, or intolerance to an SGLT-2 inhibitor.

Step	Requirement / Historical notes
MRA trial/failure required
Trial and failure, contraindication, or intolerance to a mineralocorticoid receptor antagonist (MRA) such as spironolactone or eplerenone is required prior to approval.
SGLT2 requirement (historical modification)
Policy history: a prior step required SGLT2 (e.g., Jardiance) as a step; subsequent updates allowed concomitant SGLT2 use (9/2023) and the SGLT2 requirement was modified to permit satisfaction by provider attestation (8/2025).

Background

Finerenone (Kerendia) is indicated in adults to reduce kidney and cardiovascular risk in specific populations. For chronic kidney disease associated with type 2 diabetes, the policy frames use to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular events. For heart failure indications the policy includes heart failure populations with left ventricular ejection fraction thresholds and ties expected benefit to reductions in cardiovascular death and heart failure events. Baseline renal function (eGFR), albuminuria (UACR), and serum potassium are emphasized as key clinical parameters for safe and appropriate initiation.

Definitions

CKD associated with T2D — definition used for indication

DefinitionChronic kidney disease occurring in the setting of type 2 diabetes (CKD associated with T2D)

Policy useIndication for finerenone to reduce risk of sustained eGFR decline, ESKD, and cardiovascular events

Required baseline dataDiagnosis plus UACR >=30 mg/g and eGFR >=25 mL/min/1.73 m2 are required for prior authorization

HFpEF / HFmrEF — definitions with EF thresholds

HFpEF definitionHeart failure with preserved ejection fraction (EF >=50%)

HFmrEF definitionHeart failure with mildly reduced ejection fraction (EF 40% to <50%)

Revision History

2025-08annual_review/material_changeLatest

Annual review modified the SGLT2 requirement to allow a provider attestation statement and added a new heart failure indication.

2024-10editorial_update

Updated diagnosis language and references.

2023-09coverage_expansion

OpenPayer

Kerendia (finerenone) prior authorization and medical necessity

Coverage Criteria

Clinical Thresholds & Coding

Provider Actions & Documentation Requirements

Initial Therapy Criteria by Indication

Reauthorization & Continuation Criteria

Step Therapy Requirements

Background

Definitions

Revision History